FDA.reportPublic FDA data

Medline-Microtek

Primary DI
10748426145383
Brand
Medline-Microtek
Company
Microtek Medical LLC
Model
Equipment Drapes
Catalog number
C9-106MEU
Device description
Mini C-Arm Drape, For GE OEC 6600, 104 cm x 213 cm (41 in x 84 in)
Published
2026-01-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10748426145383PackageGS110In Commercial Distribution
20748426145380PackageGS12In Commercial Distribution
00748426145386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1074842614538310748426145383
2074842614538020748426145380
00748426145386007484261453867484261453860748426145386

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-633-5463customerservice@medline.com

Regulatory Flags#

DUNS number
106908437
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00748426263448Convertors®Equipment Drapes29-290092026-06-09
00748426121861OLYMPUSEquipment DrapesOME-V2-D2026-05-28
00748426146802Medline-MicrotekFluid Warming - Warmer EquipmentEFW5L2026-05-20
00748426146925Medline-MicrotekSurgical Slush - Hush-Slush EquipmentORS-1075EU2026-05-20
00748426146932Medline-MicrotekSurgical Slush - Hush-Slush EquipmentORS-2038EU2026-05-20
00748426262076AQUABLATION THERAPY®Patient DrapesDR39002026-04-06
00748426264483Medline-MicrotekPatient Drapes5960UK2026-03-16
00748426264490Medline-MicrotekEquipment Drapes8033651EU2026-03-16
00748426264506Medline-MicrotekEquipment Drapes49652026-03-16
20748426264487Medline-MicrotekPatient Drapes5960UK2026-03-16
20748426264494Medline-MicrotekEquipment Drapes8033651EU2026-03-16
10748426264503Medline-MicrotekEquipment Drapes49652026-03-16
00748426264315Medline-MicrotekPatient Drapes59602026-02-11
00748426261543NA33206633202026-02-26
10748426261540NA33206633202026-02-26
10748426144294Medline-MicrotekEquipment Drapes5096NS2026-02-18
10748426144560Medline-MicrotekEquipment Drapes15427-002026-02-18
10748426144584Medline-MicrotekEquipment Drapes2904N2026-02-18
10748426144591Medline-MicrotekEquipment Drapes4604N2026-02-18
10748426144607Medline-MicrotekEquipment Drapes4650N2026-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00748426263448Convertors®Microtek Medical LLCPUI2026-06-09
30680651501272HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501289HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501296HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501302HalyardO&M HALYARD, INC.PUI2026-06-08
16931918100876AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918102450AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104201AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104416AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104645AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104843AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104935AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918105239AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918106977AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918107400AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918107929AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918108261AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918109640AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918109855AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918109879AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918117102AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918139449AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918179179AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
30680651424465HalyardO&M HALYARD, INC.PUI2026-06-02
50192253071595CONVERTORSCardinal Health 200, LLCPUI2026-06-02
50192253071601CONVERTORSCardinal Health 200, LLCPUI2026-06-02
50192253071618CONVERTORSCardinal Health 200, LLCPUI2026-06-02
50192253071625CONVERTORSCardinal Health 200, LLCPUI2026-06-02
00748426121861OLYMPUSMicrotek Medical LLCPUI2026-05-28
07466532979338Moon SurgicalDAS Medical International SRLPUI2026-05-28